MANTA Percutaneous Vascular Closure Device - The SAFE MANTA Study (NCT02908880) | Clinical Trial Compass
CompletedNot Applicable
MANTA Percutaneous Vascular Closure Device - The SAFE MANTA Study
United States, Canada263 participantsStarted 2016-12
Plain-language summary
Research study which tests the safety and effectiveness of a new vascular closure device to close the femoral access puncture that is created in patients who require this form of access in order to perform the planned procedure. The MANTA device is expected to seal the femoral access puncture in less than 1 minute. This may result in less blood loss and a shorter time to walking compared to alternative closure means. Use of the MANTA device in this study is experimental. All other parts of the procedure involve standard medical care.
Who can participate
Age range
21 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Candidate for elective or planned (i.e., not emergent or urgent) percutaneous transcatheter interventional procedure via a 10-18F size retrograde common femoral artery approach (i.e., transcatheter aortic valve implantation \[TAVI\], endovascular aneurysm repair \[EVAR\], Impella® use)
. Vessel size would allow for access for the MANTA device as determined by baseline CTA: minimum vessel diameter 5mm for the 14F MANTA and 6mm for the 18F MANTA
. Eligible for sheath removal in the catheterization lab
. Age ≥21 years
. Understand and sign the study specific written informed consent form
. Able and willing to fulfill the follow-up requirements
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Time to Hemostasis
Timeframe: During access site closure, usually within an hour of starting the procedure.
2
Number of Patients With Major Complications, Within 30 Days of Procedure
. In the investigator's opinion, patient is suitable for the MANTA vascular closure device, conventional hemostasis techniques and participation in an investigational trial
Exclusion criteria
. Known to be pregnant or lactating
. Immunocompromised or with pre-existing autoimmune disease
. Systemic infection or a local infection at or near the access site
. Morbidly obese or cachectic (BMI \>40 kg/m2 or \<20 kg/m2)
. Known bleeding disorder including thrombocytopenia (platelet count \<100,000 cells/UL), thrombasthenia, hemophilia, or von Willebrand disease
. Allergy to bovine materials or any other device material, including collagen and/or collagen products, polyglycolic or polylactic acid, stainless steel or nickel
. Femoral artery puncture in target groin within the prior 14 days